Shajini
CMS has issued its final payment determination for Pillar Biosciences’ oncoReveal CDx, confirming a crosswalk-based national rate of $1,352.09, service beginning January 1, 2026. The decision, which aligns with CMS’ preliminary ruling from August, marks a meaningful advance for Medicare beneficiaries and reinforces oncoReveal CDx’s position as a front-line, multi-cancer NGS testing kit in the … Read more
Today’s neurology cycle delivered four high-impact developments: Mirum’s Phase 2 start in Fragile X, FDA Breakthrough Therapy Designation for SPI-1005 in Meniere’s disease, the U.S. launch of KYMBEE for Duchenne muscular dystrophy, and Circular Genomics’ $15M Series A to advance circRNA-based Alzheimer’s detection.
Omeros has finalized the handoff of its clinical-stage MASP-3 monoclonal antibody zaltenibart (OMS906) to Novo Nordisk, closing a transaction that delivers immediate liquidity, removes near-term financing overhangs, and validates a complement-pathway mechanism increasingly viewed as one of the next competitive frontiers in immunology. The deal, first signed in mid-October, brings Omeros $240 million at closing … Read more
Korea delivered two breakthrough reimbursement decisions, opening transformative access to Ultomiris for refractory generalized myasthenia gravis and elevating Jemperli to first-line status in dMMR/MSI-H endometrial cancer.
The Reimbursement Landscape Recalibrates As we pause for the Thanksgiving holiday, a sincere thank-you to our readers and partners for your continued engagement. This week’s update reflects a period of meaningful policymaking momentum across major global agencies. Across the U.S., UK, France, Canada and Thailand, agencies delivered firm, directional decisions that shape how hospitals, clinics … Read more
Reimbursement Momentum Favours SKYRIZI, Tagrisso and Cosentyx Friday brought major reimbursement shifts in Canada and Korea, recalibrating near-term access in inflammatory bowel disease, EGFR-mutated lung cancer and hidradenitis suppurativa. AbbVie secured a major win in Canada as SKYRIZI moved closer to funded access for ulcerative colitis. In Korea, reimbursement recalibration strengthened Tagrisso’s advantage over Leclaza … Read more
Pacira has sued WhiteOak and Qilu after ANDA filings for generic EXPAREL, initiating a 30-month FDA stay and strengthening its defense of 21 Orange Book patents.
Neuraxpharm and mjn-neuro will launch EPISERAS, an AI-based earpiece that predicts seizures minutes in advance, offering real-time alerts for patients with drug-resistant epilepsy.
RWE Demonstrates Significant Four-Year MACE Reduction Repatha (Evolocumab), Amgen’s PCSK9 inhibitor, has once again demonstrated its cardiovascular impact, this time in a real-world population exceeding 110,000 patients. New findings presented at the American Heart Association Scientific Sessions 2025 show that the therapy delivers sustained, long-term reductions in major adverse cardiovascular events (MACE) for patients with … Read more
AI Imaging Advances, ALS Pipeline Progress, and New CMS Reimbursement Gains Signal Steady Momentum in a Holiday-Quiet Neurology Cycle Even as Thanksgiving week typically slows the flow of biotech and medtech announcements, the neurology sector delivered a trio of meaningful developments across imaging innovation, neurodegenerative drug progress, and federal reimbursement policy. Together, they reflect a … Read more